Ortho Women's Health & Urology Release: ORTHO EVRA(R) Prescribing Information Updated
Published: Jan 21, 2008
RARITAN, N.J., Jan. 18 /PRNewswire-USNewswire/ -- Ortho Women's Health & Urology(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has updated the prescribing information for ORTHO EVRA(R) (norelgestromin/ethinyl estradiol transdermal system) to include further epidemiologic data.
The revised labeling includes two new additional estimates of relative risk (odds ratios) for venous thromboembolic events (VTE) of 1.1 (indicating no increase in risk) and 2.0 (indicating an approximate doubling of risk) in women using ORTHO EVRA compared to women using birth control pills. The previous labeling reported two estimates of relative risk for VTE of 0.9 (indicating no increase in risk) and 2.4 (indicating an approximate doubling of risk). This information is presented in a table in the WARNINGS section and is available at www.fda.gov and www.orthoevra.com. The results from all of these epidemiologic studies can be found on www.clinicaltrials.gov or by calling Ortho-McNeil Janssen Scientific Affairs, LLC Customer Communications Center at 1-800-526-7736.
The detailed patient information for ORTHO EVRA also has been revised to include this information in the OTHER CONSIDERATIONS BEFORE USING ORTHO EVRA section.
ORTHO EVRA is a hormonal birth control option and is safe and effective when used according to the product label. The Company consulted with the U.S. Food and Drug Administration on this label change. ORTHO EVRA, like all hormonal birth control, has risks and benefits. It is important that women speak to their health care professional to determine the option that is right for them.
ORTHO EVRA is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception.
For more information about ORTHO EVRA, please visit www.orthoevra.com, call Ortho-McNeil Janssen Scientific Affairs, LLC Customer Communications Center at 1-800-526-7736 or contact your health care professional.
Important Safety Information
Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use the contraceptive patch are strongly advised not to smoke.
The pharmacokinetic (PK) profile for the ORTHO EVRA patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations (60% higher) and lower peak concentrations (25% lower) of ethinyl estradiol (EE) compared with an oral contraceptive containing 35 mcg EE. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using ORTHO EVRA compared with women using oral contraceptives containing 35 mcg EE. Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism. (See CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives, BOLDED WARNING in the Package Insert).
The results of epidemiologic studies evaluating the risk of venous thromboembolism (VTE) among women using ORTHO EVRA compared to those using oral contraceptives containing 30-35 mcg EE and either levonorgestrel or norgestimate reported odds ratios ranging from 0.9 (no increase in risk) to 2.4 (approximate doubling of risk).
The Patch does not protect against HIV or sexually transmitted diseases.
Please see full U.S. Prescribing Information at www.orthoevra.com.
About Ortho Women's Health & Urology(TM)
Ortho Women's Health & Urology(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a leader in the fields of women's health and urology, celebrating more than 75 years of partnering with women. Ortho Women's Health & Urology is committed to helping people live healthier lives and to meeting the needs of providers and patients with products such as ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol), ORTHO EVRA(R) (norelgestromin/ethinyl estradiol transdermal system), and ELMIRON(R)(pentosan polysulfate sodium). For more information on these products, birth control, bladder health or general women's health issues, please visit www.orthowomenshealth.com.
CONTACT: Gloria Vanderham of Ortho Women's Health & Urology,
Web site: http://www.clinicaltrials.gov/